PET Imaging of Cholesterol Trafficking with FNP-59

This study is testing a new imaging agent called FNP-59. FNP-59 is a "radiotracer" (a substance that helps show things on scans) designed to improve how we see cholesterol in the adrenal glands using a PET/CT scan. Researchers want to see if FNP-59 can be used safely and effectively to image the adrenal gland in healthy people. The main goal is to measure how much FNP-59 is taken up by your adrenal glands. You might be able to join if you are an adult (18 or older), do not have adrenal problems, are not pregnant, and are not taking certain medications like steroids or oral contraceptives. The current status of this study is unclear.

Study design
This is an interventional study, meaning participants will receive an intervention. It plans to enroll 6 healthy volunteers.
What's involved
You would receive FNP-59 for PET/CT scans. The primary measurement of FNP-59 uptake in your adrenal glands will be taken on Day 0.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 0, which suggests a short follow-up period.

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NCT04532489

Positron Emission Tomography (PET) Imaging of Cholesterol Trafficking: Clinical Evaluation of [18F]FNP-59 in Normal Human Subjects (Group 1)

Recruiting
EARLY_PHASE1Ages 18+InterventionalHealth services
Benjamin Viglianti
~6 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:FNP-59

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentation
Measured over Day 0
Radiotracer
Hypertension
Cholesterol
1 sites across 1 states
Michigan1
  • Ben Viglianti, M.D, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

Participants without any known adrenal pathology as normal controls for radiation dosimetry purposes

Exclusion

Pregnancy
Unable to do imaging
Body weight greater than 400 lbs (181 Kg)
Prisoners are not eligible
Subjects unable to provide own consent are not eligible
Current use of steroids, Oral contraceptives (OCP), spironolactone, estrogen, androgen, progesterone, Angiotensin-converting enzyme (ACE inhibitors)/ Angiotensin II receptor blockers (ARBs), or supplements that are hormone analogues.
Known adrenal pathology
  • Uptake for [18F]FNP-59 in the adrenal glands using the standardized uptake value (SUV) based on gland segmentationDay 0

    SUV will be reported. Both maximal and average SUVs will be calculated